Sources Sought Notice.pdf

Sources Sought Notice

IHS-JVN Teleophthalmology Program Support Contract

Title: IHS-JVN Teleophthalmology Program Support Contract Agency: Indian Health Service Issue Date: Monday April 6, 2026 Due Date: Monday April 20, 2026, no later than 5:00pm EST POCs: Responses must be submitted via email to cynthia.cason@ihs.gov and hillary.marshall@ihs.gov and. Include “Teleophthalmology – Your Company Name” in the Subject of the email.

This Sources Sought Notice (SSN) is for market research and planning purposes only and shall not be construed as a solicitation or an obligation or commitment to issue a solicitation by the Indian Health Service (IHS). This SSN is seeking information from the specific types of entities listed below to assess their capabilities in fulfilling the requirements set forth in this SSN. The information from this SSN will be used to determine the appropriate set-aside, if any, in accordance with the applicable regulations listed. The Government encourages the identified to respond to this Notice and will be assessed of their capabilities in the following priority:

1. Indian Small Business Economic Enterprises (ISBEE)

2. Indian Economic Enterprises (IEE) in accordance with HHSAR 326.603-1

3. Small business concerns in accordance with FAR 19.502-2 (b)(1) & (2)

Responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether any ISBEE/IEE or small business set-aside is possible based on the Contracting Officer’s reasonable expectation of obtaining offers from two or more relevant concerns that will be competitive in terms of market price, product quality, and delivery capability. An organization that is not considered an ISBEE/IEE firm OR small business under the applicable NAICS code should NOT submit a response to this notice. The applicable primary NAICS code for this requirement is 541690 - Other Scientific and Technical Consulting Services. The anticipated period of performance for this effort will be one year from the date of award, with up to four additional one-year option periods.

Generic capability statements are not sufficient and may not be considered when assessing entity capabilities.

Background The Indian Health Service (IHS) is the principal federal health care provider and health advocate for Indian people, and its goal is to raise their health status to the highest possible level. IHS provides a comprehensive health service delivery system for approximately 2.3 million American Indians and Alaska Natives (AI/AN) who belong to 573 federally recognized Tribes in 37 states. IHS has 12 Area Offices and 10 Accounting Offices across the United States. These offices support the extensive health care delivery network and provide managerial, financial and administrative support to the hospitals, clinics and health centers. All work under this contract shall be performed in direct support of the IHS Office of Finance, and Accounting (OFA) and Area Offices (including their respective facilities) within the IHS.

The Indian Health Service Teleophthalmology Program uses the Joslin Vision Network (JVN) system, which is a specialized teleophthalmology modality for the remote diagnosis and management of diabetic retinopathy (DR). The Joslin Vision Network operates within the Comprehensive Diabetes Management Program (CDMP), a suite of software applications residing on the IHS JVN/CDMP server that provides multiple functions critical to the clinical operation of the JVN including patient clinical record management, database maintenance, clinical and administrative reporting, quality assurance (QA), Resource and Patient Management System/Electronic Health Record (RPMS/EHR) interoperability, and Digital Imaging and

Communications in Medicine (DICOM) image management. As such, the CDMP serves as the platform for clinical operation of the JVN in the Indian Health Service (IHS).

Deployment and use of the JVN system in the IHS allows participating facilities to image the retina of patients with diabetes for the purpose of remote diagnosis and recommendations for referral and management of diabetic retinopathy (DR). This allows timely diagnosis and treatment, thereby reducing avoidable vision loss among AI/AN’s. This is a critically important program from both clinical and regulatory vantage points.

Diabetic Retinopathy is the leading cause of blindness amongst working age adults. Serious vision loss from diabetes can be nearly eliminated by timely diagnosis and treatment of high-risk disease. Before the IHS-JVN Teleophthalmology program was implemented, the sustained annual Diabetic Retinopathy examination rate in NA/AI patients was ~50%. In FY 2024, the IHS-JVN Teleophthalmology program alone captured 26,284 studies of American Indians/Alaska Native (AI/AN) patients, with ~25% identified with high risk findings. Those patients with high risk findings are at risk for progressing to blindness if not identified by imaging or dilated examination. In that same fiscal year, the IHS-JVN program deployed 18 new cameras, totaling 113 active sites in 27 states. Continued growth of the program is anticipated based on historical data and ongoing interest from clinics across the country.

The first clinical deployments of the IHS-JVN Teleophthalmology program began in the year 2000 and have continued incrementally. Currently there are 123 sites in 25 states (113 active in 2025). The majority of cameras deployed are stationary, while portable cameras provide services with additional outreach to small or remote locations. The IHS-JVN Teleophthalmology program uses the JVN technology to acquire, transmit, store/retrieve, interpret, and report retinal images from AI/AN’s with diabetes. These images are maintained on servers that operate on the IHS wide area network (WAN), and are routinely visible only by IHS reader staff to ensure the privacy of AI/AN patients. Evaluation of these images by IHS readers occurs at the National Reading Center using specialized reading and reporting software. This allows the remote diagnosis of level of Diabetic Retinopathy with development of a referral and treatment recommendations consistent with established standards of care. As a contingency of its use in the IHS, the system has been validated and operates at the American Telemedicine Association (ATA) Category 3 level, providing a DR diagnostic accuracy equal or better than a conventional dilated retinal examination. More importantly, this allows the majority of patients to be diagnosed and followed or referred remotely. If they progress to specific levels of DR, appropriate referrals and recommendations are made, thereby minimizing inconvenience and expense for the patient and increasing efficiencies for the hosting site.

Purpose and Objectives The general purpose of this contract is to maintain ongoing development, implementation, and support of the IHS-JVN Teleophthalmology activities in Urban Indian Health Care clinics, Tribal Health Clinics and Indian Health Service hospitals and clinics with software, services and equipment. These software, services and equipment are provided by the vendor.

Capability Statement/Submission Information A response to this SSN will be in the form of a capability statement to demonstrate capability and experience in the task areas identified further below. Specifically, please provide the following information below to demonstrate capabilities:

Cover Page Please provide a cover page to include:

1. Company Name

2. Company Designation (ISBEE/IEE/SB)

3. Type of Business – as applicable (e.g. 8(a), Woman Owned Small Business, HUBZone, etc.)

4. UEI Number

5. Point of contact, email address, and phone number

6. Primary NAICS Code(s)

7. Existing federal contracting vehicle(s) numbers, as applicable (e.g. GSA MAS number, NITAAC/CIO SP3, other Government Wide Agency Contracts, etc.)

8. System for Award Management (SAM) registration status. Note, all respondents must be registered on the SAM located at http://www.sam.gov/ prior to any potential award.

Executive Summary Provide a high-level overview of your services and include how it will benefit the Indian Health Service.

Technical Areas Respondents are expected to submit a capability statement detailing and demonstrating their expertise and technical capabilities in the areas outlined further below in this SSN.

Past Performance Please provide any past performance information to support demonstration of your capabilities in the relevant technical areas and magnitude of work.

Other Information (Optional) You may include any other information that may be helpful in developing or finalizing the requirements of the potential acquisition.

Submission Format To assist the Government in an expeditious review of your capabilities, the capability statement should be organized as follows:

Cover page Executive Summary Technical Areas in the order listed Past Performance Other Information, as applicable

The tailored capability statement should not exceed 10 pages excluding Past Performance information. Font must not be less than 10 point (for readability) and may be submitted in either in either Microsoft Word or Adobe Portable Document Format (PDF) but must be a standard 8-1/2 by 11 inch in paper size. All proprietary information should be marked as such.

Generic capability statements are not sufficient and will not be considered compliant with the requirements of this notice.

Disclaimer and Important Notes This notice does not obligate the Government to award contract. Any information provided by industry to the Government as a result of this SSN is strictly voluntary. Responses will not be returned. No entitlements to payment of direct or indirect costs or charges to the Government will arise as a result of contractor submission of responses or the Government's use of such information. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s capabilities to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published on a government GPE. However, responses to this Notice will not be considered adequate responses to any resultant solicitation.

Confidentiality. No classified, confidential, or sensitive information should be included in your response.

The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Thank you for your interest in IHS programs.

Task 1: OPERATIONS (SERVICE)

Description of Work

Provide primary infrastructure support for all ongoing operations Support end-to-end Quality Assurance (QA) of the IHS-Teleretinal (IHS-TR) program at the

National Operations & Reading Center and assist with data for peer review, efficiency and other analysis.

Assist in maintaining an externally pointing Web site for the IHS-JVN Teleophthalmology program in collaboration with the IHS OIT web development division to maintain ihs.gov/Teleophthalmology website

Develop and maintain an internally pointing Web site for the IHS-TR Teleophthalmology program to support end-users of the program.

Set all critical requirements, test, and certify all imaging and reading workstations for compatibility with IHS-TR’s GRI (Global Retinal Imager) software and all other IHS-TR technology, for safe and effective clinical use.

Support regulatory compliance (e.g. FDA registration).

Assist in continuous program improvement through outcome analysis and epidemiologic review.

Engage in the development and support of emerging clinical advancements to include new camera technologies, Artificial Intelligence (AI) image evaluation/reporting and active buildout, management and support of an AI Program

The vendor shall provide support for ongoing imager Training, Quality Assurance, Clinical Research and Publication support, including, but not limited to:

o Standardized training and certification programs:

Support Imager acquisition training (training materials) Reader certifications: Provisional and Full o On-going review of System, Imager, and Reader performance, providing data as needed o Program specific, Institutional Review Board (IRB) supervised research publications on key public health and teleophthalmology topics relevant to AI/AN patient population Camera system validation Programmatic reviews Prevalence of eye disease in AI/AN patient population Artificial Intelligence/Machine Learning

Ensure program and staff compliance with all IHS security and privacy standards.

IHS-JVN contractor staff require clearance at the “Public Trust – High Risk” level to access program data and equipment.

The program must achieve and maintain all of the following in order to be used as a replacement for live eye exams:

o The vendor must be able to support, where needed, the American Telemedicine

Association’s (ATA) - Ocular Telehealth-Diabetic Retinopathy Practice Guidelines (3rd Edition) – at the Category 3 level or higher. The following excerpt summarizes those requirements:

“Category 3 validation indicates a system can identify ETDRS defined levels of non-proliferative DR (mild, moderate, or severe), proliferative DR (early, high-risk), and DME with accuracy sufficient to determine appropriate follow-up and treatment strategies

Performance: the system can distinguish patients with ETDRS-defined clinical levels of NPDR (mild, moderate, or severe), proliferative DR (early, high-risk), and DME (central-involved DME or not central-involved DME) to match conventional clinical retinal examination through dilated pupils or ETDRS photos.

Clinical application: Category 3 validation allows patient management to match clinical recommendations based on clinical retinal examination through dilated pupils.

The diagnostic capabilities thereby allowing remote diagnosis and recommendations based on the level of DR.

o The vendor must follow an ISO 13485 certified and registered Quality Management System (QMS) for vendor management, software development and program management.

o The vendor’s offering must have a current FDA medical device (510k) clearance.

o The vendor’s offering must conform to relevant portions of both the DICOM and IHE

(Integrating the Healthcare Enterprise) Eyecare file format and messaging standards.

o The vendor’s offering must be listed on the Department of Veterans Affairs (VA) VistA

Imaging approved list for Ophthalmic Photography image acquisition devices.

o The vendor must have conducted research and published evidence that their tele-retinal surveillance offering is as effective as an in-clinic evaluation for Diabetic Retinopathy.

o The vendor’s proposed camera’s retinal images must be equivalent to the clinical “gold standard” Early Treatment of Diabetic Retinopathy Study’s (ETDRS) Seven Standard Field Photography imaging protocol.

o Patient visits utilizing the vendor’s offering must qualify for Medicaid reimbursement (Arizona required, US wide strongly preferred) o Patient visits utilizing the vendor’s offering must qualify for inclusion in the IHS’ GPRA Diabetic Retinopathy Exam numerator.

Deliverables/Tasks and Subtasks

Subtask 1.1 - Quality Assurance – (Deliverable) Extensive work has been done to develop a data set for QA purposes. Reader testing and data monitoring for quality assurance metrics will be accomplished through the use of the IHS-JVN Teleophthalmology software (currently JVN/CDMP). The vendor QA team shall work closely with the IHS team to complete the work required for measuring reader quality to establish a robust QA program for the IHS-TR.

Subtask 1.2- Quality Improvement – (Deliverable) Utilizing the data monitoring tools developed for the quality assurance module the vendor team shall, upon the request of the IHS-JVN Teleophthalmology Program Director, collaborate with the IHS team to perform data analyses and identify specific areas where quality improvement is indicated. Once a particular area of quality improvement has been identified, the hypothesis can be tested through a study. The data collected will allow an evaluation of a particular quality improvement hypothesis with respect to clinical or business case scenarios within the IHS program.

Subtask 1.3- Risk Management (Deliverable) Maintain records for identifying and tracking technical risks to the program and actively participate with the IHS to mitigate these risks in compliance with IHS risk management requirements.

Subtask 1.4 -Ongoing Program Analysis (Deliverable)

The vendor shall conduct ongoing scientific evaluation and review of the program. The vendor shall work with the Director to develop and review all required Internal Review Board (IRB) materials, extract and process relevant datasets, and develop reports and peer-reviewed academic manuscripts. The vendor’s research and data scientists shall only present materials at conferences or other forums that have been cleared by the IHS.

Subtask 1.5 - Emerging Clinical Technologies

The vendor shall maintain expertise in Diabetic Retinopathy identification and surveillance techniques including emerging technologies such as computer aided image review, Artificial Intelligence based image assessments, and automated treatment planning. The vendor shall inform and update the director on emerging technologies.

As directed, the vendor shall conduct technology assessments, technology reviews and software development to integrate new technologies into the IHS-TR program.

Subtask 1.6 -Program Expansion/Growth and Support The vendor shall provide, when requested, an Optometrist reader to support expansion and growth of the program. The Optometrist must be certified by the Joslin Vision Center, Joslin Diabetes Center, Boston.

The optometrist may perform up to 40 working hours per week, as requested by the IHS-JVN Teleophthalmology Program director. The optometrist reader interprets teleophthalmology images to diagnose and recommend follow-up for of a wide range of eye diseases to include, but not limited to, the conditions of diabetic retinopathy; hypertensive retinopathy; glaucoma and retinal diseases; and ophthalmic telephone-consultation for urgent and emergent diagnoses. Serves as a contact liaison for trained imagers in order to assist with trouble shooting with cameras and imaging. Participates, as a member of the JVN team, in imager training of staff from across the nation and Teleophthalmology research.

The vendor shall assist the IHS-JVN Teleophthalmology program leadership by referring any clinics that have expressed interest in the program to the Director.

Subtask 1.7 - Advanced camera system identification, testing, validation Vendor and IHS Teleophthalmology Program staff will collaborate to continue defining requirements for a proper telemedicine retinal imaging system and then maintain market vigilance for new devices that may offer additional features. Upon identification of a new advanced retinal camera appropriate for clinical deployment in the IHS-JVN Teleophthalmology program, the vendor will explore its potential through testing and validation in collaboration with IHS-JVN.

Camera systems must be validated and generally require a prospective, IRB approved study involving ~50 research subjects with varying documented levels of Diabetic Retinopathy.

Subtask 1.8 –Website Development and Support:

Internal marketing and customer education is an important feature for competent telemedicine operations and should be included in the IHS-JVN Teleophthalmology Program. This web-based communication platform includes an online description of the program in a context relevant, culturally sensitive, and regulatory compliant fashion. This support is provided by the vendor web development staff in collaboration with the IHS-JVN Teleophthalmology director and the IHS OIT Web Manager. OIT is the predominant resource for this externally pointing site, but the vendor participation is required for operational consistency and content management. This is an ongoing process that is documented by the web posting of an externally pointing web site with content development occurring collaboratively by IHS and the vendor, and approved by the IHS-JVN Teleophthalmology Program Director.

Assistance in the development and maintenance of an internally pointing IHS-TR web site is needed to facilitate cost efficient, effective, and regulatory conformant operations. This web site must contain document repository, broadcast communication, education/training, and QA/CQI functions. The basic architecture of this site has been developed. While the OIT Web Manager is a resource in this effort, the predominant source of the web site development and support is the vendor. This is done in close association with the IHS-TR Director and vendor Program Manager.

Subtask 1.9 –Training:

The vendor shall work with the IHS clinical team to provide initial IHS-JVN Teleophthalmology Reader training and provisional certification of optometrist reader trainees as needed to accommodate new hire IHS reading staff. It is understood that there may be no need to replace or expand the IHS-JVN Teleophthalmology Reader staff, but this option is provided to accommodate attrition or unanticipated growth. IHS-TR readers will also undergo program peer review that will ensure that the expectations of clinical excellence are maintained throughout the program. Data and support, as requested, will be provided by the vendor as needed.

When requested, the vendor shall review the IHS clinical review curricula for imager training course to ensure that evolving clinical guidelines are met and that training material is appropriate for the IHS.

All Reader training provided by the vendor shall be supplied at a location mutually agreed by the IHS-JVN Teleophthalmology Program and the vendor. The default location will be at the vendor training location, but circumstances may drive an alternate location to suit staffing and logistic convenience of the vendor and the IHS.

Task 2 - LOGISTICAL SUPPORT (SERVICE)

Description of Work

Provide onsite service and support including introduction, orientation, staff training (clinical, technical, business), deployment, logistics, and troubleshooting of operational problems following deployment.

Upgrade existing and end of life hardware and software with program validated components.

Provide a national support helpdesk with minimum hours of 8am-8pm Eastern Time.

Provide a mechanism (specialized software) for users of Imaging workstations at IHS-JVN

Teleophthalmology sites to view reports and retinal images in a non-diagnostic presentation state for program patients at their site.

Provide repairs to imaging devices, cameras, workstations, and other IHS-JVN Teleophthalmology program equipment and related devices, including repair by replacement with logistic support.

Maintain inventory of all IHS-JVN equipment. Assist IHS Headquarters and the IHS-JVN national operations/reading center with IHS inventory management and reporting. Including delegated management authority.

Provide support to the National Reading Center, including responsibility for image evaluation workstations and ancillary Reading Center equipment.

Deliverables/Tasks and Subtasks:

Subtask 2.1 Deployment/On-site support logistics: Deployment of cameras to IHS, Urban and Tribal sites will occur throughout the United States. For specific cameras, imager training will also be required at the time of deployment. This requires a technical specialist to travel to the deployment/re-deployment/upgrade site. Onsite technical support by this specialist may also be required for non-deployment service issues at any of the existing IHS-JVN sites. The actual cost for logistic support of a specific deployment or service visit varies based upon location and other market variables.

Any particular IHS/Tribal/Urban site deployed, re-deployed, upgraded, or receiving onsite technical service under this contract is determined on an ad hoc basis during the term of this contract so a precise timeline for this activity cannot be established in advance.

Subtask 2.1.1 –New Site Deployment (Typical) Service (Deliverable)

Step 1- Participate in Pre-Deployment Call/Meeting

Tasks:

Notified by IHS-JVN Teleophthalmology Program Director of planned deployment sites and appropriate contacts

Vendor will arrange a pre-deployment call/meeting and submit an agenda to the IHS-JVN Teleophthalmology Program Director

Vendor will conduct the pre-deployment call/meeting for issues related to deployment. This meeting may include the Program Director or may be performed independently.

Output:

Vendor will notify the Program Director of the date/time for the pre-deployment call/meeting schedule

Resources:

IHS Program Management

Related Documentation:

Pre-Deployment Questionnaire IHS-RPMS Implementation Checklist

Step 2- Gather Pre-deployment Information

Tasks:

Conduct Pre-Deployment Call. Identify scope of IT components of the clinical program. Identify group members and roles Review Pre-Deployment Questionnaire

Discuss site preparation and Imaging Room Connectivity Review IHS-Teleophthalmology program installation tasks Review RPMS tasks

Review Support Procedures Review Property Inventory Management Review Biomed Property Inspection Review IT access Schedule deployment and Schedule imager training Establish communication plan Conduct Follow-up sessions to collect remaining information

Output:

Pre-Deployment Questionnaire Complete

Resources:

IHS Program Management Local Site Contacts (MOU) Vendor Deployment Specialist

Related Documentation:

OHS-Site MOU

Step 3 — Procure and Deliver Equipment

Order all equipment based on output from Pre-Deployment Conference Call

Output:

Equipment delivered at pre-staging area of the deployment site Equipment remains unopened

Resources:

Vendor Program Manager Vendor Deployment Specialist

Related Documentation:

Procurement Information

Steps 4 and 5- Off-Site Technical Pre-Deployment Prep Work and Local Readiness Confirmation

Arrange for Travel Logistics for Deployment Specialist Pre-Stage Equipment Confirm with IHS Program Management readiness of local site Ship Equipment to Sites Confirm Receipt of Equipment at Sites

Output:

Ready for On-Site Deployment

Resources:

Vendor Program Manager Vendor Deployment Specialist

Workstation Configuration/Installation Document Inventory Tracking and Workstation Information Forms

Steps 6 & 7 & 8 - Prepare Local Site and Confirm Readiness

Ensure location for system is appropriate and ready for deployment When upgrading: Ensure connectivity of IHS-JVN Workstation by pinging IHS-JVN server from workstation data drop with local IT staff assistance as needed Check for/Install EMR/RPMS Environment for required applications and patches Provide local RPMS access and Area VPN access to vendor QA Personnel Establish remote Health Summary print device Back-up RPMS installation Confirm Imager training by IHS Imager training scheduled

Output:

Local Site Ready for On-Site installation IHS-RPMS Implementation Checklist complete

Resources:

IHS Program Management Local site contacts

OIT

Related Documentation

IHS-RPMS Implementation checklist

Site Deployment Services

On-Site Deployment

Step 9 — Perform On-Site Set-up of Equipment

Tasks:

Set-up Imaging System (Camera, table, accessories) Set-up and configure Workstation Final Imager Orientation to camera, imaging software, and RPMS interface

Output:

Camera and Workstation Function locally Imager able to operate related RPMS and IHS-JVN software Imager able to capture IHS-JVN image series Imager able to transmit health summary

Site Imager

Deployment Instruction Guide

Step 10 — Integration Testing

Ensure test patients scheduled in RPMS appear in IHS-JVN work list without error Ensure that test studies are stored locally and in the IHS-JVN server, and can be retrieved from

IHS-JVN without error

Output:

Deployment Test Procedures Complete

Resources:

Vendor Deployment Specialist

Related Documentation

Deployment Test Procedures

Step 11 — Provide On-Site Administrative and Imager Training (as needed) to Local Technical Contact(s)

Tasks:

Review maintenance procedure Review virus protection Windows Updates Review procedures if network configuration changes are necessary Review support process/procedures Imager training (for specific cameras)

On-site Training Sign-off complete

Resources:

IHS On-site technical contact(s)

Related Documentation

IHS-JVN On-site Maintenance Procedures Site Deployment Services:

Post-Deployment

Steps 12 & 13 — Create Post-Deployment Summary

Document on-site tasks completed, not completed, and open issues remaining Complete IHS-JVN equipment tracking database including make/model, serial numbers/manufacturer’s service tags, etc.

IHS Program Management to review and suggest edits

Post-Deployment Summary complete and distributed to appropriate parties

Vendor Deployment Specialist

IHS-JVN Post-Deployment Summary Template

Subtask 2.1.2 – Existing System Support – Service (Deliverable) Logistic support of onsite service and support of the IHS-JVN at 120+ current sites and anticipated new AI/AN sites for remote support as well as site inspections, staff orientation and training, maintenance, repairs, and equipment updates that cannot be accomplished remotely. These events occur incrementally throughout the contract year and the incremental costs vary with the location, neither of which can be precisely predicted.

Subtask 2.1.3 -Support Services The following describes the plan to provide comprehensive IHS-JVN customer support for the IHS as well as IHS-JVN’s management of third- party vendors on behalf of the IHS. It contains a brief overview of the support plan, workflow and procedures of the support infrastructure for both the central IHS-JVN Help Desk as well as Field Support.

Support Escalation Workflow IHS-Teleophthalmology Program Support or Help Desk shall be staffed weekdays between the hours of 8 AM and 8 PM ET. It will consist of three levels of service that will interact seamlessly to manage the entire service environment for the IHS systems.

Level 1: The Help Desk Liaison is the first point of contact for IHS customer support. This occurs at the level of the IHS and is usually not performed by the vendor except in a fail-over condition. All inbound issues will be logged, recorded and then passed off to either Level 1 or Level 2 support personnel. IHS clinical personnel at the IHS-TR offices shall provide Level 1 clinical support, which is primarily associated with clinical and camera use issues and other problems requiring entry level technical support. Level 1 support issues will typically be resolved by the end of the phone call or via email response. Any issue that cannot initially be resolved by Level 1 support shall immediately be escalated to Level 2 support.

Level 2: All technical problems associated with computer hardware, operating systems and IHS-TR software that cannot be addressed by Level 1 are elevated to Level 2 vendor Technical support. Support issues at the IHS level are triaged and routed to appropriate support personnel. If Level 2 cannot resolve the issue within 24 hours of assignment, it will be forwarded to Level 3 support.

Level 3: Level 3 Support consists of both IHS-Teleophthalmology program software application support as well as third-party vendor management. Any technical problem associated with vendor-supplied products is escalated to Level 3 support. Vendor Level 2 support personnel shall contact the appropriate third-party vendor(s) on behalf of the IHS and continue to manage the issue until it is resolved. In the case of third-party vendor issues, Level 3 support resolution shall be dependent upon the various service contracts negotiated by Vendor. Resolutions for IHS-Teleophthalmology program software issues will be dependent upon the determined level of severity.

Subtask 2.1.4 - Other Specific Support Services RPMS/EHR-IHS-TR technology Interface support: The vendor shall collaborate with IHS OIT to ensure appropriate interface support and documentation of issues and their resolution. The vendor is expected to have sufficient RPMS/EHR expertise to perform basic troubleshooting and vendor side interface management. Only those cases requiring more advanced RPMS/EHR expertise should involve IHS OIT or contractor staff.

Account Management: The vendor and IHS shall collaborate on identifying and documenting technical, clinical, and administrative issues that arise from IHS-Teleophthalmology program operations. The identified contact person shall establish a liaison between the vendor and IHS to ensure that issues are resolved expeditiously and that issues are documented as part of the IHS-Teleophthalmology program Lessons Learned documentation process.

IHS-Teleophthalmology program Tools Support: These tools would include Quality of Service tools for performance expectations. The vendor shall collaborate with IHS in establishing these tools to provide performance enhancement of the clinical program.

IHS-Teleophthalmology program Deployment Support: The vendor team shall coordinate with IHS team to coordinate deployments and triage of support issues.

Telecom support: the vendor team shall work with IHS team to ensure that appropriate telecom support is available for the IHS-TR program.

The vendor shall monitor site productivity to identify sites with reduced imaging frequency and determine if reduced imaging sites have IT or other issues that need to be addressed. The vendor shall then inform the IHS team when there are no IT issues at these sites to account for reduced imaging.

The vendor shall monitor new imager studies and gradability rates, identifying imagers who have successfully completed the requirements and are eligible for full certification. The vendor will send certificates to imagers that have become fully certified.

Epidemiologic studies: The vendor team shall work with the IHS team to identify epidemiologic trends among AI/AN’s using existing data derived during the normal operation of the IHS-TR.

Advanced grading studies: The vendor team shall work the IHS team to identify and validate emerging grading technologies that may improve the accuracy and/or efficiency of grading operations.

Subtask 2.1.5- Quarterly Repairs – (Deliverable) Vendor Technical Team shall provide repairs to IHS-Teleophthalmology Program technology as needed and requested. It is understood that the cost of repairs during the contract year can be only estimated based upon historical levels and anticipated event rate and the relative impact of operational idiosyncrasies as they become manifest. In certain circumstances the nature of the failure, and economic and timeline dependencies, drive a decision for repair, temporize, or defer repairs.

Task 3 - SOFTWARE MAINTENANCE AND ENHANCEMENT (Deliverable)

Description of Work

Support the transmission of stereoscopic color digital retinal images to an IHS staffed reading center using store-and-forward mode through the IHS-TR software platform (currently GRI/JVN)

Maintain and enhance the integrated Reader system to allow for seamless expansion and accommodation of program growth. Provide software solutions including new features, enhancements, and new software systems to support Reader workstations and Reading Center workflow.

Integrate the IHS-Teleophthalmology Program technology into IHS Medical Record systems through bidirectional standards-based interoperability (DICOM, HL7, IHE), including all existing image acquisition devices (Optos Daytona and CenterVue Eidon).

Collaborate with OIT software development teams to support interoperability of additional telehealth service delivery modules such as Remote/Home Monitoring, and creation of interfaces between IHS Medical Record systems and IHS-TR technology.

Develop, test, and provide ongoing enhancements of an interface between the programs validated camera systems and IHS-TR imaging software - Global Retinal Imager (GRI).

Provide maintenance and updates of third-party software and renewal of third-party software as needed for data and image management.

Conduct continuous research and development to ensure the program utilizes the most current and effective clinical solutions.

Deliverables/Tasks and Subtasks:

Subtask 3.1 -Integration Services:

IHS-TR technology/RPMS (and/or IHS-wide EMR) Integration comprises all software requirements for operational integration of the IHS-TR technology into the IHS HIT including interoperability with

RPMS/EHR/VI.

Prior to the capture of retinal images of a patient, demographic information about the patient is sent from the Resource and Patient Management System (RPMS) utilizing the RPMS-Generic Interface System (GIS), or its operational equivalent. The RPMS GIS supports the development and implementation of interfaces using multiple messaging protocols such as Health Level 7 (HL7) and HLO, and distributed as patches to the RPMS GIS. A GIS RPMS interface for the IHS-TR technology (currently JVN/CDMP) was developed, verified, and is in use to support the information exchange described.

Specific Integration Services

Information technology project management and support: The vendor team shall collaborate with IHS-Teleophthalmology Program and OIT team to identify and prioritize new interoperability use cases and management issues and formulate procedures for resolution.

Architectural Support: The vendor team shall collaborate with IHS-Teleophthalmology Program and OIT to define technical specifications as they evolve with respect to the IHS-TR imaging and reading application and IHS-Teleophthalmology Program shall provide the associated quality systems documentation.

Standards and Messaging Support: The vendor team shall collaborate with the IHS- Teleophthalmology Program and OIT teams to ensure that IHS-Teleophthalmology Program requirements continue to be supported by IHS-Teleophthalmology Program and RPMS/EHR infrastructure.

RPMS Interface development: the vendor team shall collaborate with IHS to coordinate bilateral software development for functional integration of the IHS-Teleophthalmology Program technology applications and workflow with RPMS/EHR. The prime outcome of this collaboration is to ensure that IHS-Teleophthalmology Program technology software development will continue to meet RPMS/EHR interfacing requirements including specified standards based automated workflow and other interfaces as specified by the IHS-TR Director.

Facilitate potential integration of the IHS-Teleophthalmology Program technology with other existing and planned IHS HIT entities, such as VistA Imaging (VI) and other telemedicine acquisition modalities, and provide vendor qualification services and technology validation for potential system vendors or adoption of new technologies such as different retinal imaging cameras.

Interim programming comprises all ad hoc programming needed to deal with unplanned development issues. By definition, an anticipated volume, scope, and timeline cannot be provided.

Subtask 3.2.-Image transmission Using an ISO-13485 certified Quality Management System, the vendor shall develop, maintain and enhance image capture and transmission processes and software to ensure all patient images are delivered to the National Reading Center.

Subtask 3.3. - Reading Software Using an ISO-13485 certified Quality Management System, the vendor shall develop, maintain and enhance image review and analysis software to ensure accurate human and/or technology-based image review. The vendor shall ensure efficient and compliant production of patient imaging session reports and treatments plans.

Subtask 3.4.-Imaging software Using an ISO-13485 certified Quality Management System, the vendor shall develop, maintain and enhance image acquisition software to efficiently support Patient imaging workflows. The vendor shall ensure the imaging software supports all deployed retinal imaging systems.

Subtask 3.5. - Integration Services In coordination with national and local clinical IT staff, the vendor shall develop, maintain and enhance IHS-TR technology/RPMS Integration. Integration shall minimally include patient registration/scheduling and final report submission.

Subtask 3.6 - Additional related tele-health integrations The vendor shall work with other IHS programs as directed to support, advise, develop, maintain and deploy other related integrations.

Subtask 3.6.1 - Special Requirements of Support Activities:

During the provision of support services, the vendor shall occasionally have access to federal information and/or information systems. At all times, the vendor must satisfy applicable provisions of the Health Insurance Portability and Accountability Act (HIPAA), The Privacy Act, Federal Information Security Management Act (FISMA), HHS/IHS Rules of Behavior (as applicable) and the Homeland Security Presidential Directive (HSPD-12) to ensure the identity of the staff with access and to protect the confidentiality, integrity, and availability of sensitive federal information and/or information systems. At all times, all the vendor staff with access to federal information systems must have all required certification and clearances. Currently these include: Public Trust – High Risk clearance and full administrative privileges to the D1’s JVN Administrators group (requires ALT card/certificate and current IHS system administrator certificates).

EQUIPMENT & SUPPLIES

The nature of telemedicine in general and the IHS-TR in particular requires strict attention and adaptability to the evolution of technology and its clinical application (new technology, new use cases for existing technology, orphaned technology, new operational requirements, etc).

The Contractor shall provide the following equipment and supplies as follows:

TELEOPHTHALMOLOGY PLATFORM –(Deliverable) This software is purchased, installed, configured, and maintained by the vendor.

The vendor shall provide a complete platform with the following functionality and which can be verified to support all of the requirements for clinical use as listed in the Operations services section above.

Core server and EHR capabilities:

o Retinal image archive with online (instant) access for 5+ million retinal images

Fundus Photographs (JPG, TIFF) DICOM compliant for OP, XC formats o Incoming Study processing service to support 100+ concurrent imaging locations.

Unified retinal imaging platform key features:

o Operator is presented a patient worklist with search and real-time image transfer status tracking.

o Operator may enter patient specific clinical data collection within the image capture flow.

Data to include:

Diabetes status (A1C, onset date, etc.)

Key (validated) risk factors for Diabetic Retinopathy progression Current Diabetes therapy Last eye exam o Operator is presented an imaging platform specific, guided image capture protocol with reference images, including full support for the following retinal camera systems:

Optos Daytona – Full patient and image integration.

Two Images OU

DRS-Plus (or equivalent) – Full patient and image integration.

Two or Three Images OU (as per the program Director)

CenterVue Eidon – Full patient and image integration Three Image OU o Full support for Priority read requests o Operator is presented the final image set verification prior to submission.

Image review platform:

o Clinical staff are presented the same prioritized worklist of studies to review o For each study, Clinical staff shall have available:

Images from the current study, all prior studies and ETDRS standard reference images regardless of imaging system used to acquire images

Ability to compare, adjust and manipulate any image (Optos Daytona, Eidon, DRS-Plus)

Protocol specific, integrated image review workflow

Reading Center Operations and Study Evaluation System o Clinical staff are presented a worklist that has been pending, in-progress and consultation requested studies Capacity to evaluate 30,000 – 50,000 patient studies annually o Clinical staff have the ability to record detailed patient information including:

Study Metadata Imager collected patient Diabetes Status and Study Details.

o Detailed Clinical Findings (technical grade) Observed Diabetic Retinopathy lesions/findings as compared to ETDRS standard images.

Other finding and observations (ARMD, Disc findings, etc.)

Grader comments (formatted free text) Image quality evaluation o Diagnosis and Treatment Plan (patient read) Validated, algorithm to assign diagnoses (computer assisted decision support):

Non-proliferative Diabetic Retinopathy

Proliferative Diabetic Retinopathy Diabetic Macular Edema

Reader comments Patient specific treatment plan to address:

Level of Diabetic Retinopathy Identification of risk-factors for disease progression Follow-up and referral treatment recommendations, including risk factors and type of referral.

o Including quick-select of common text

Electronic study completion/signature

Remote sites have access to a Web Accessible Telemedicine Reporting Service o Imaging site portal application to securely access:

Verify study grading status Review current and prior study reports Review non-diagnostic quality study images for education / reference

The National Reading Center shall have an Operations Dashboard displayed on a 40” or greater interactive/touch screen monitor.

o Real-time, map-based system overview, including:

Site locations with activity indicator System wide and site-specific study volume Summary of all eye disease identified in the last seven days, quarter and year

The major components of the current IHS-JVN clinical system include:

o Reading workstations (Currently JVN-Reader/JVN-Reporter o Imaging workstations (Currently GRI) o Report Access (Currently JVN-WATERS) o IHS-JVN server (Currently JVN) o IHS Operations dashboard (Currently JVN-CPM) o Bi-directional HL7 EMR interfaces (Currently JVN Server) o IHS WAN

Current required foundation software:

Software: Oracle RDBMS o Annual license for the Oracle software on the JVN/CDMP Server

Software: Oracle WebLogic o Annual license for the WebLogic software on the JVN/CDMP Server

Software: LeadTools o Annual license for the LeadTools software on the JVN/CDMP server and GRI workstations.

Software: Visual Studio 2019 or more advanced.

o Annual subscription for software enhancement/maintenance IDE.

OPTOS (STATIONARY) EQUIPMENT/DEPLOYMENT PACKAGE - (Deliverable) Optos Daytona (or equivalent) non-mydriatic retinal camera with shipped workstation and one-year maintenance agreement. Package Specifications:

Non-mydriatic imaging Wide angle retinal image capture- 200° angular subtend Scanning laser imaging of the retina Auto-Fluorescence imaging DICOM conformance statement for OP Storage SOP; Wide Field Image OP Storage SOP conformance.

At least one formal validation study appropriately powered and controlled against ETDRS demonstrating ATA Category 3 performance or higher.

Optos workstation w/GRI v3.x or better (see item 6(A) for full specification).

Optos Daytona control tablet stand (adjustable arm style).

Shipping

The nature of the camera system deployment process is such that this occurs on an ad-hoc basis for which a precise timeline for acquisition cannot be established in advance. As per the usual deployment process, these devices are either shipped directly from the manufacturer to the deployment site or to the vendor for storage, where they are secured and remain in their original packaging until inspected and accepted by the program’s deployment specialist. Biomed inspection/tagging and property management inventory intake then occurs as per HHS/IHS policy and the MOU with the deployment site.

MOBILE CAMERA EQUIPMENT/DEPLOYMENT PACKAGE - (Deliverable) Package includes: Camera System, Travel Case, and Laptop (only option). These items have the following specifications:

CenterVue EIDON (or equivalent) True Color Confocal Scanner At least one formal validation study appropriately powered and controlled against ETDRS demonstrating ATA Category 3 performance or higher.

Scanner with dust cover, lens cloth, operator manual (English).

EIDON 12 month warranty Eidon travel cases Laptop based imaging workstation w/GRI 3.x or greater (see item 6(B) for full specification).

The nature of camera system deployment process is such that this occurs on an ad-hoc basis for which a precise timeline for acquisition cannot be established in advance. As per the usual deployment process, these devices are shipped directly from the manufacturer to the deployment site or to the vendor for storage, where they are secured and remain in their original packaging until inspected and accepted by the program’s deployment specialist. Biomed inspection/tagging and property management inventory intake then occurs as per HHS/IHS policy and the MOU with the deployment site.

SMALL STATIONARY CAMERA (DRS-PLUS or equivalent) EQUIPMENT/DEPLOYMENT

PACKAGE – (DELIVERABLE)

Package includes: Camera System, Travel Case and Laptop (only option). These items have the following specifications:

DRS-Plus Camera (or equivalent as approved by the program Director) Equipment/Deployment Package

At least one formal validation study appropriately powered and controlled against ETDRS demonstrating ATA Category 2 performance or higher.

Lens cloth, operator manual (English).

12-month warranty Case

Laptop based imaging workstation w/GRI 3.x or greater (see item 6(B) for full specification).

The nature of the camera system deployment process is such that this occurs on an ad-hoc basis for which a precise timeline for acquisition cannot be established in advance. As per the usual deployment process, these devices are either shipped directly from the manufacturer to the deployment site or to the vendor for storage, where they are secured and remain in their original packaging until inspected and…